Announcement of the State Drug Administration on Issuing the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs
Announcement of the State Drug Administration on Issuing the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs
Announcement of the State Drug Administration on Issuing the Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs
Announcement of the State Drug Administration [2018] No.52
July 6, 2018
The Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs, which were formulated by the State Drug Administration in order to implement the Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices (Ting Zi [2017] No.42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and better guide and regulate the acceptance of overseas clinical trial data of drugs are hereby promulgated.
The Announcement is hereby given.
Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs
I. Scope of Application
The Principles apply to the guidance on the acceptance of overseas clinical trial data used as a clinical evaluation reference by applicants applying for registration of drugs in the People's Republic of China.
Overseas clinical trial data under the Principles includes without limitation the overseas clinical trial data obtained by applicants through the research and development of innovative drugs conducted synchronously at home and abroad. Clinical trial data derived from the overseas research and development of generic drugs can also be used for registration application, provided that there is complete and evaluable bioequivalence data.
II. Basic Principles for Acceptance of Overseas Clinical Trial Data
Applicants shall ensure the truthfulness, completeness, accuracy and traceability of overseas clinical trial data.
The process of how overseas clinical trial data is formed shall comply with the relevant requirements stated in the Good Clinical Practice ("GCP") provided by the International Conference on the Harmonization of the Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).
Applicants shall also ensure that overseas clinical trials are designed scientifically, with a quality management system for clinical trials meeting the relevant requirements, and the statistical analysis of data is accurate and complete.
To ensure the scientific soundness and reasonableness in the design of clinical trials and the statistical analysis of data, for drugs that have been researched and developed synchronously at home and abroad and will undergo clinical trials in China, applicants may, before conducting key clinical trials, communicate with the Center for Drug Evaluation of the China Food and Drug Administration (the "CFDA CDE") to ensure that key clinical trials are designed in compliance with the basic technical requirements for drug registration in China.
III.
......
Announcement of the State Drug Administration [2018] No.52
July 6, 2018
The Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs, which were formulated by the State Drug Administration in order to implement the Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices (Ting Zi [2017] No.42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and better guide and regulate the acceptance of overseas clinical trial data of drugs are hereby promulgated.
The Announcement is hereby given.
Guiding Technical Principles for the Acceptance of Overseas Clinical Trial Data of Drugs
I. Scope of Application
The Principles apply to the guidance on the acceptance of overseas clinical trial data used as a clinical evaluation reference by applicants applying for registration of drugs in the People's Republic of China.
Overseas clinical trial data under the Principles includes without limitation the overseas clinical trial data obtained by applicants through the research and development of innovative drugs conducted synchronously at home and abroad. Clinical trial data derived from the overseas research and development of generic drugs can also be used for registration application, provided that there is complete and evaluable bioequivalence data.
II. Basic Principles for Acceptance of Overseas Clinical Trial Data
Applicants shall ensure the truthfulness, completeness, accuracy and traceability of overseas clinical trial data.
The process of how overseas clinical trial data is formed shall comply with the relevant requirements stated in the Good Clinical Practice ("GCP") provided by the International Conference on the Harmonization of the Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).
Applicants shall also ensure that overseas clinical trials are designed scientifically, with a quality management system for clinical trials meeting the relevant requirements, and the statistical analysis of data is accurate and complete.
To ensure the scientific soundness and reasonableness in the design of clinical trials and the statistical analysis of data, for drugs that have been researched and developed synchronously at home and abroad and will undergo clinical trials in China, applicants may, before conducting key clinical trials, communicate with the Center for Drug Evaluation of the China Food and Drug Administration (the "CFDA CDE") to ensure that key clinical trials are designed in compliance with the basic technical requirements for drug registration in China.
III.
......